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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K110597
Device Name EV1000 CLINICAL PLATFORM
Applicant
Edwards Lifesciences
One Edwards Way
Irvine,  CA  92614
Applicant Contact MARGUERITE THOMLINSON
Correspondent
Edwards Lifesciences
One Edwards Way
Irvine,  CA  92614
Correspondent Contact MARGUERITE THOMLINSON
Regulation Number870.1435
Classification Product Code
DXG  
Date Received03/02/2011
Decision Date 06/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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